Biology Experiment

Why Need to You Attend:

Particulates in Biologics injectibles can arise from the aggregation of the protein item. It has been suggested that the aggregated material presents a safety concern due to the fact it increases the possibility of formation of anti drug antibodies. The FDA has as a result requested BLA sponsors to present sub-visible particulate information at the clinical and commercial stage and has identified the .2 – 10 micron as a range where there is a lack of suitable strategies for testing particles. Whether or not the aggregates in protein therapeutics genuinely increase the immunogenicity of the item is not entirely clear and continues to be debated in the industry. Nevertheless this debate has increased the scrutiny of reviewers on the testing and reporting of particulates in Protein Therapeutics.

This webinar addresses recent discussions in the industry related to testing sub-visible particulates in Biologics injectibles. Recent FDA expectations for reporting information will be discussed. Methods for characterization and routine testing of particulates, their advantages and limitations will be discussed. Case studies where the numerous techniques have been employed for characterization of the sub-visible particles will be discussed.

Areas Covered in the Seminar:

Why test for sub-visible particulates in protein therapeutics.
Present expectations for testing for particulates in protein therapeutics.
USP technique for particulate testing in injectibles.
Commonly utilized ‘work-horse’ strategies for particulates: SEC and SDS-PAGE.
AUC and FFF.
Light scatter approaches.
Imaging techniques.
Electronmicroscopy.

Who Will Benefit:

R&ampD Laboratory personnel
R&ampD Laboratory Supervisors and Management
QC Laboratory personnel and management
Protein Formulation Group personnel and Management
Regulatory Affairs personnel
Regulatory Affairs Management
QC Laboratory personnel and management

Instructor Profile:
Nanda Subbarao, Dr. Subbarao received her Ph.D. in Bio-organic Chemistry from the Indian Institute of Technologies, Bombay, India. Her hands-on industrial expertise covers stability and laboratory cGMP systems for both biologics and conventional drugs. She has extensive expertise in evaluation of analytical techniques and approach validation for products ranging from conventional drugs, well characterized proteins, vaccines, cell therapy and gene therapy goods, ranging from pre-clinical phase to commercial phases.

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